For the first time since 2012, ISO 15223-1 has been updated. The full title of this document is “Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General Requirements”. This document will lay out for you all the requirements for a wide variety of medical device label symbols. As I’m sure many of you current users of ISO 15223-1 already know, this standard is an important one. If medical devices are your game, you’ll want to pick this one up ASAP. It’s available now from Document Center as a paper copy or for PDF download.
Certain information must be conveyed when presenting a new medical device. Much of this information is vitally important to the proper and safe use of the device. It is also mandated by regulation in the US, EU, Canada, and many more. This can pose a problem when marketing a device that must be presented in various geographic locations and languages. The solution to this problem? Create a series of internationally recognized symbols, detailed within ISO 15223-1 2016 Edition. This document was designed to take the confusion out of labeling medical devices in different languages. In doing so, it helps to ensure the safe use of the products that it applies to.
Detailed within this text you’ll find a discussion of the scope of the document and who it applies to. Requirements for usage of the medical device labels that are presented are covered. Following this is an extensive “Symbols” section. This includes a 16-page series of tables showing the symbols themselves. It also provides their titles, descriptions, requirements, and informative notes.
The document finishes with two informative annexes. Annex A gives practical examples of how each symbol is used to convey information. Some examples are manufacturing location, use-by date, and batch code. Annex B provides guidance on general prohibition and negation symbols.
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